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January 2011


Ellen Leinfuss

Seven Signs that Your Quality Program is in Trouble

by Ellen Leinfuss
SVP, Life Science, Kaplan Eduneering

Product quality problems don't happen overnight, nor are they the result of a crippled procedure or one poorly conceived policy. The problems have brewed over time, sending out signals that risks to product quality are growing.

Because of the unique nature of medical products and the expectations of prescribers and patients, failed product quality translates into a betrayal of trust. It is a safety and brand issue, and problems are on the rise, as evidenced by the 300 percent increase in drug recalls experienced this past year.

A breakdown of quality is not an event. It is a process. Long before a quality failure explodes on the front page of the New York Times, a company's quality system has been in trouble because of corporate decisions, policies and programs. In this paper, we identify the following seven "signs" that often indicate future quality problems and offer guidance in addressing associated challenges.

One of the signs is a lack of support from "the top." There is no substitute for a powerful "tone at the top" but recent corporate crises have shown that tone by itself is not enough to support quality. Companies widely considered to be the quality leaders in their fields have been battered by quality problems, in part because of a disconnect between the company's message to the public and to its own employees. Toyota has become an iconic example of this "message disconnect." According to industry experts, Toyota's leadership set a blistering production pace at the same time it systematically slashed operating costs. Despite the public statements of leaders reiterating the company's legendary commitment to quality, Toyota's policies sent a very different and clear message to employees and suppliers: quantity and cost trump quality. The consequences of that unspoken message were played out this year through massive recalls and investigations by national enforcement agencies across the globe.

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